DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP
K963387 · Morrison Medical Products · FMQ · Nov 8, 1996 · General Hospital
Device Facts
| Record ID | K963387 |
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| Device Name | DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP |
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| Applicant | Morrison Medical Products |
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| Product Code | FMQ · General Hospital |
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| Decision Date | Nov 8, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 880.6760 |
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| Device Class | Class 1 |
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| Attributes | Pediatric |
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Intended Use
The Morrison Medical Products Limb Restraint with Double D-Ring and Strap is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting position.
Device Story
Protective limb restraint device; limits patient movement for treatment, examination, or safety. Construction: foam/fabric laminate reinforced with polyester webbing strap. Closure mechanisms: double D-ring or hook-and-loop. Available in adult, youth, and infant sizes. Used in clinical settings; applied by healthcare providers. Benefits: prevents patient injury or interference with medical procedures.
Clinical Evidence
No clinical data. Biocompatibility review of materials indicated low potential for adverse skin reaction; no reports of skin irritation noted.
Technological Characteristics
Materials: foam/fabric laminate, polyester webbing. Closure: double D-ring or hook-and-loop. Sizes: adult, youth, infant. Mechanical restraint device; no energy source or software.
Indications for Use
Indicated for patients requiring limb movement limitation for treatment, examination, or protection of the patient or others. Applicable to adult, youth, and infant populations.
Regulatory Classification
Identification
A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
Predicate Devices
- Limb Restraint with Double D-Ring and Strap
- Limb Restraint with Strap
Related Devices
- K963466 — PEDIATRIC LIMB HOLDER · Deroyal Industries, Inc. · Feb 13, 1997
- K963473 — REUSABLE LIMB HOLDER · Deroyal Industries, Inc. · Nov 14, 1996
- K963469 — MITTENS · Deroyal Industries, Inc. · Nov 14, 1996
- K963468 — RESTRICTIVE LIMB HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
- K963413 — MULTIPLE LIMB HOLDERS · J. T. Posey Co. · Nov 14, 1996
Submission Summary (Full Text)
{0}
K963387
M
MORRISON MEDICAL PRODUCTS
NOV - 8 1996
# Morrison Medical Products
## Limb Restraint with Double D-Ring and Strap
# Safety and Effectiveness Summary
## 1. Submitter's name, Address and Contact Person
| Submitter | Contact Person |
| --- | --- |
| Morrison Medical Products
610 W. Town Street
Columbus, OH 43215-4446 | Joseph S. Tokarz; Manager, Regulatory Affairs
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
Ph: (847)680-2849, Fax: (847)918-3860 |
Date Summary Prepared - August 26, 1996
## 2. Name of Device:
Limb Restraint with Double D-Ring and Strap
Limb Restraint with Strap
## 3. Name of Predicate Device(s)
Limb Restraint with Double D-Ring and Strap
Limb Restraint with Strap
## 4. Description of Device
Morrison Medical Products has developed two limb restraints that are intended to be a protective restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The following is a description of the two limb restraints.
Limb Restraint with Double D-Ring and Strap:
The Double D-Ring and Strap limb restraint uses it its construction a foam/fabric laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient’s limb using a double D-ring closure mechanism.
The Limb Restraint with Double D-Ring and Strap is available in the following size:
Stock No. 1114
Adult Size:
Cuff size: 11½" long x 2½" wide
Strap: 1" wide x 60" long
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610 WEST TOWN STREET
COLUMBUS, OH 43215
FAX 614•469•96•96
614-461-4400
{1}
M
MORRISON MEDICAL PRODUCTS
# Morrison Medical Products
## Limb Restraint with Double D-Ring and Strap
**Limb Restraint with Strap:**
The Limb Restraint with Strap is constructed of a foam laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient using a hook and loop closure.
The Limb Restraint with Strap is available in the following sizes:
| Stock No. 1103 | Adult size | Cuff size: 11½" long x 2½" wide
Strap: 1" wide x 60" long |
| --- | --- | --- |
| Stock No. 1124 | Youth size | Cuff size: 9" long x 2" wide
Strap: 1" wide x 36" long |
| Stock No. 1119 | Infant size | Cuff size: 6" long x 1¼ wide
Strap: 1" wide x 24" long |
## 5. Statement of Intended Use
The Morrison Medical Products Limb Restraint with Double D-Ring and Strap is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting position.
## 6. Statement of Technological Characteristics of the Device
The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency’s labeling requirements set forth in the draft “Guidance on the Content of Premarket Notification [510(k)]” Submissions for Protective Restraints” dated December 1995.
## 7. Biocompatibility
The subject devices are identical in component materials to the predicate devices. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction.
Page 20
610 WEST TOWN STREET
COLUMBUS, OH 43215
FAX 614•469•96•96
614-461-4400
{2}
MORRISON MEDICAL PRODUCTS
# Morrison Medical Products
## Limb Restraint with Double D-Ring and Strap
### 8. Conclusion
Based upon the information presented above it is concluded that the proposed Morrison Medical Products Limb Restraint with Double D-Ring and Strap is safe and effective for its intended use and is substantially equivalent to the predicate device.
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610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400
